Medical Device School: Product Development or Documentation creation?
I am sure you were once on this situation where you started to develop a Medical Device and when you finished all the tests, and estimate that your product is good, then you want to put it on the market. When regulators ask you for your design documentation your mind then has a bug.
On this bonus episode of the Medical Device made Easy Podcast, Stefan Bolleininger, and Monir El Azzouzi will explain to you when you should develop first your product and when you should develop your documentation.
This episode can save you some time and understanding of the process. So don’t miss it
Who is Stefan Bolleininger?
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.
He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.
In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Easy Medical Device: https://easymedicaldevice.com
- Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Medical Device Startups – Here are the secrets of success: https://www.medicaldesignandoutsourcing.com/medical-device-startups-secrets-success/
- 5 FDA Myths that Startup believe: https://podcast.easymedicaldevice.com/45/